510(k) K251440— CRYOcheck Chromogenic Factor VIII

Substantially Equivalent

Precision Biologic, Inc.

Clearance details

Applicant: Precision Biologic, Inc.
Product code: Code GGP
Advisory panel: Hematology
Date received: 2025-05-09
Decision date: 2025-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dartmouth, CA

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